ENDOTAK RELIANCE SG Adverse Events: FDA MAUDE Data
BOSTON SCIENTIFIC CORPORATION · Permanent Defibrillator Electrode (Lead) · First cleared Aug 1993
Total Reports
3,470
Reports (30d)
40
Active Signals
0
Open Recalls
4
What the reports describe · Claripulse analysis
Most commonly reported problems
Gradual Rise in Shock Impedance
impedance measurements, measurements, remains service, shock impedance, ohms
39
reports
Lead Replaced for Performance Anomaly
reported right, product performance, successfully, additional adverse, new lead
5
reports
High Pacing Impedance Measurements
measurements, pacing, impedance, remains service, service
5
reports
Lead Revision Due to Infection
explanted right, infection additional, revision infection, additional adverse, lead revision
5
reports
ICD High Shock Impedance Measurements
measurements, icd, shock, shock impedance, range shock
5
reports
CRT Lead High Shock Impedance Alert
resynchronization, cardiac resynchronization, crt, therapy, service
4
reports
Problem groupings are generated by Claripulse from report narrative text. They summarize what reporters wrote, not adjudicated root cause.
Regulatory
FDA recalls for this device
Jul 24, 2025 · Open, Classified
Affected lead models may experience gradually rising LVSI measurements in association with calcification of the defibrillation lead coils. The issue may lead to early lead replacement. Most serious harm is death or need for cardiac resuscitation.
Jul 24, 2025 · Open, Classified
Affected lead models may experience gradually rising LVSI measurements in association with calcification of the defibrillation lead coils. The issue may lead to early lead replacement. Most serious harm is death or need for cardiac resuscitation.
Sep 30, 2022 · Open, Classified
There is an incorrect manufacturing date/timestamp within the software which causes an inaccurate display of battery capacity.
Sep 30, 2022 · Open, Classified
There is an incorrect manufacturing date/timestamp within the software which causes an inaccurate display of battery capacity.
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